Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach

Recruiting now · Not applicable

Conditions studied: Heart Failure

In brief

Cardiac resynchronization therapy（CRT） benefits a portion of patients, while more patients are not yet indicated to a therapy that mechanically helps the heart systole and/or diastole. Synchronized diaphragmatic pacing may be feasible to induce diaphragm local contraction and recoil that enhance pump function of the heart, thus improve cardiac function and QoL. This acute, interventional study is conducted in a single site, Renji Hospital, to evaluate the feasibility of diaphragm pacing and assess the beneficial effect of pacing-regulated diaphragm movement to the heart, with 10 cases of sample size and one-week follow-up after discharge.

Key facts

Study ID

NCT07392749

Run by

RenJi Hospital

People needed

10

Starts

2025-11-28

Expected to finish

2026-03-31

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged >=18 yrs;
• Patients indicated for CRT or CRT-D , planned for LV lead implantation;
• Patients are willing to participate in the study and provide signed informed consent

You may not qualify if…

• CRT or CRT-D replacement
• Ischemic heart disease with CABG history
• Diaphragm dysfunction history
• Phrenic nerve injury
• IVC filter history
• Abdominal surgery history
• Splenomegaly
• Pulmonary disease
• Moderate or severe liver cirrhosis
• Severe hepatic or renal dysfunction
• Currently pregnant or planning pregnancy during the study period
• Patients participate in another study that will confound this study

Where it is running

• Renji Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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